Diabetic peripheral neuropathy (DPN) develops in 30% of type 2 diabetes patients, increases the risk for foot ulcers and amputation, and is a significant source of disability and medical costs. Treatment remains challenging, propelling research to focus on therapeutic methods that aim to improve blood circulation or ameliorate oxidative stress that drives development of DPN. The aim of this study was to assess the effectiveness of acupuncture treatment for DPN symptoms and lower extremity arterial circulation in people with type 2 diabetes. Twenty-five patients seen at a Southern California Tribal Health Center who reported a threshold level of diabetic neuropathy symptoms in the lower extremities during the previous 4 weeks received acupuncture treatment once per week over a 10-week period between 2011 and 2013. The Neuropathy Total Symptom Scale (NTSS-6), Neuropathy Disability Score (NDS), and laser Doppler fluxmetry (LDF) were used for assessment at baseline and 10 weeks. A total of 19 of 25 study participants completed the study and reported a significant reduction in the NTSS symptoms of aching pain, burning pain, prickling sensation, numbness, and allodynia. Lancinating pain did not decrease significantly. LDF measures improved but not significantly. Acupuncture may effectively ameliorate selected DPN symptoms in these American Indian patients.
AIMS: The aim of this study was to assess whether surgical decompression of nerves in the lower extremity in people with painful diabetic polyneuropathy would have an effect on health-related quality of life and to determine minimal clinically important differences in pain and quality of life scores.
METHODS: The design was a randomized controlled trial in which 42 participants with painful diabetic painful neuroapthy underwent unilateral decompression of nerves in their left or right leg, using the other leg as a control, with 12 months follow-up. Surgical decompression was performed at the tibial, superficial, deep and common peroneal nerves. Preoperatively, and at 6 and 12 months post operatively, a visual analogue scale for pain and the 36 item short-form health survey and EuroQual 5 Dimensions questionnaires were completed.
RESULTS: At 12 months follow-up, the visual analogue scale was significantly reduced, but decompression surgery did not significantly alter health-related quality of life scores. The minimal clinically important difference for visual analogue scale reduction was determined at 2.9 points decrease, a threshold reached by 42.5% of the study population.
CONCLUSIONS: Although decompression surgery does not influence health-related quality of life, it achieves a clinically relevant reduction of pain in ~42.5% of people with diabetic peripheral neuropathy. It can therefore be considered for patients who do not adequately respond to pain medication.
BACKGROUND: The authors aimed to assess the effect of lower extremity nerve decompression surgery for painful diabetic polyneuropathy on pain and sensibility.
METHODS: The study was conducted as a single-center randomized controlled trial of one intervention with 1-year follow-up. Forty-two patients with painful diabetic neuropathy were included. After randomization, the lower extremity nerves were decompressed at four sites in one limb. The contralateral limb was used as control (within-patient comparison). All patients were assessed preoperatively and at 3, 6, and 12 months postoperatively. Primary outcome was the visual analogue scale score 12 months after surgery. Secondary outcomes were Semmes Weinstein monofilament testing and two-point discrimination outcomes at 3, 6, and 12 months.
RESULTS: Visual analogue scale scores improved significantly from a mean of 6.1 (95 percent CI, 5.5 to 6.7) preoperatively to 3.5 (95 percent CI, 2.5 to 4.4) at 12 months postoperatively (p<0.001). The score was also significantly lower compared with the control leg score of 5.3 (95 percent CI, 4.4 to 6.2; p<0.001) at 12 months. Overall, 73.7 percent of the patients improved their score on the visual analogue scale, of which 35.7 percent had a decrease of more than five points.
CONCLUSION: Surgical decompression of the nerves of the lower extremity can be added as a therapeutic option for patients with painful diabetic neuropathy who show signs of chronic nerve compression by means of a positive Tinel or other diagnostic criteria, when pain medication fails to reduce pain to an acceptable standard.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
BACKGROUND: Diabetic neuropathic pain can severely influence quality of life, and patients may be dissatisfied with treatment.
OBJECTIVE: To carry out an observational study of the effects of acupuncture for the treatment of diabetic neuropathic pain, in preparation for a full study.
METHODS: Nine patients with diabetic neuropathic pain were recruited from a Korean diabetic clinic and given 12 sessions of acupuncture over 4 weeks. Their symptoms were evaluated using the Total Symptom Score (TSS) and Michigan Neuropathy Screening Instrument (MNSI) at baseline and 4 weeks after the last treatment.
RESULTS: Mean TSS scores reduced from 7.99 (SD 3.55) at baseline to 4.95 (SD 4.41), at the 8-week follow-up-a statistically non-significant change (p=0.057). The MNSI scores improved from 6.33 (SD 1.31) before treatment to 4.33 (SD 3.00) after acupuncture treatment-a significant improvement (p=0.010). One participant experienced an exacerbation of diabetic neuropathy symptoms, but two patients gained complete relief of their diabetic peripheral neuropathy (DPN) symptoms.
CONCLUSIONS: The results of this study justify further investigations into the effects of acupuncture on DPN.
OBJECTIVE: Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus. Unfortunately, pharmacological treatment is often partially effective or accompanied by unacceptable side effects, and new treatments are urgently needed. Small observational studies suggested that spinal cord stimulation (SCS) may have positive effects.
RESEARCH DESIGN AND METHODS: We performed a multicenter randomized clinical trial in 36 PDPN patients with severe lower limb pain not responding to conventional therapy. Twenty-two patients were randomly assigned to SCS in combination with the best medical treatment (BMT) (SCS group) and 14 to BMT only (BMT group). The SCS system was implanted only if trial stimulation was successful. Treatment success was defined as ≥50% pain relief during daytime or nighttime or "(very) much improved" for pain and sleep on the patient global impression of change (PGIC) scale at 6 months.
RESULTS: Trial stimulation was successful in 77% of the SCS patients. Treatment success was observed in 59% of the SCS and in 7% of the BMT patients (P < 0.01). Pain relief during daytime and during nighttime was reported by 41 and 36% in the SCS group and 0 and 7% in the BMT group, respectively (P < 0.05). Pain and sleep were "(very) much improved" in 55 and 36% in the SCS group, whereas no changes were seen in the BMT group, respectively (P < 0.001 and P < 0.05). One SCS patient died because of a subdural hematoma.
CONCLUSIONS: Treatment success was shown in 59% of patients with PDPN who were treated with SCS over a 6-month period, although this treatment is not without risks.
Painful diabetic neuropathy (PDN) is a peripheral neuropathic pain condition that is often difficult to relieve. Spinal cord stimulation (SCS) is a proven effective therapy for various types of mixed neuropathic conditions, yet effectiveness of SCS treatment for PDN is not well established. To our knowledge, ours is the first multicentre randomized controlled trial investigating the effectiveness of SCS in patients with PDN. Sixty patients with PDN in the lower extremities refractory to conventional medical therapy were enrolled and followed for 6 months. They were randomized 2:1 to best conventional medical practice with (SCS group) or without (control group) additional SCS therapy, and both groups were assessed at regular intervals. At each follow-up visit, the EuroQoL 5D, the short form McGill Pain Questionnaire (SF-MPQ) and a visual analogue scale (VAS, ranging 0-100) to measure pain intensity were recorded. The average VAS score for pain intensity was 73 in the SCS group and 67 in the control group at baseline. After 6 months of treatment, the average VAS score was significantly reduced to 31 in the SCS group (P<.001) and remained 67 (P=.97) in the control group. The SF-MPQ and EuroQoL 5D questionnaires also showed that patients in the SCS group, unlike those in the control group, experienced reduced pain and improved health and quality of life after 6 months of treatment. In patients with refractory painful diabetic neuropathy, spinal cord stimulation therapy significantly reduced pain and improved quality of life.
